The Effect of Thyroid Hormone Levels in Pregnant Women on the Intelligence Quotient (IQ) of Their Children
Status unconfirmed
Conditions studied: Child Development Disorders, Pregnancy, Subclinical Hypothyroidism
In brief
This study is designed to test the hypothesis that the level of the thyroid hormone thyroxine (specifically, free thyroxine, FT4) circulating in the blood of pregnant women is the key thyroid-related factor to influence early fetal brain development. The investigators will recruit 5000 pregnant women with clinically normal thyroid function (normal thyroid stimulating hormone levels) in the second trimester. After the baby has been born, the investigators will measure FT4 in the second trimester maternal blood sample to identify 100 cases (very low FT4 levels) and 100 matched controls (normal FT4 levels). The children of cases and controls will undergo neurodevelopmental testing at 2 years of age to determine whether IQ differs according to maternal FT4 levels during pregnancy. The potential impact of the study is that if such an effect is found, it might be possible to avoid these adverse developmental consequences in children by designing and testing strategies to identify and treat high risk women.
Key facts
- Study ID
- NCT00147433
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 5000
- Starts
- 2004-02-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2006-03-31
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant female
- Normal TSH in second trimester
- Singleton pregnancy
- Term infant weighing 2500g or more
- No congenital abnormalities noted on birth record
- Delivery in Maine at 36 weeks or later
You may not qualify if…
- TSH levels outside normal range in second trimester
- Pre-existing hypothyroidism, treated
- More than one fetus
- Premature and/or low birth weight infant
- Congenital abnormalities noted on birth record
Where it is running
- Foundation for Blood Research — Scarborough, Maine, United States (enrolling)
Full record on ClinicalTrials.gov
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